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Biotechnology Innovation Org., et al. v. Alex M. Azar II, et al.   (N.D. Cal.)

Challenging “Most Favored Nation” rule which creates price controls on pharmaceutical drugs

The NAM filed an amicus brief in support of the pharmaceutical industry's challenge to the Trump administration's Most-Favored Nation (MFN) Rule. The rule, which bypassed the notice and comment process that agencies must ordinarily follow before making rules effective, creates a new payment model for Medicare Part B drugs, tying payments for certain drugs (a set of 50 that encompass a high percentage of Medicare Part B drug spending) to the lowest price paid by other wealthy countries. In this case, the NAM filed an amicus brief in the Northern District of California in support of plaintiffs'--the Biotechnology Innovation Organization (BIO) and two California-based biotechnology organizations--motion for preliminary injunction. A near-identical case was filed in the District of Maryland by the Pharmaceutical Research and Manufacturers of America (PhRMA) and groups representing cancer treatment providers. The NAM's brief argues that the MFN rule is yet another fatally flawed attempt by the government to use the COVID-19 pandemic as the basis for an end-run around the Administrative Procedure Act's (APA) notice and comment procedures. The NAM's members have a vital institutional interest in ensuring that the federal government is held to the procedural safeguards provided in the APA.

Happily, oOn December 28, 2020, the district court granted the plaintiffs' motion for a preliminary. Injunction .


Related Documents:
NAM brief  (December 17, 2020)
Order Granting Preliminary Injunction  (December 17, 2020)